Effect of Sacubitril/Valsartan Versus Valsartan on Left Ventricular Ejection Fraction and Biomarker in Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- LVEF %
研究概览
简要总结
The objective of this study was to identify potential prognostic factors of sacubitril/valsartan vs Valsartan treatment response.
详细描述
Study will include 80 symptomatic patients with chronic HFrEF (left ventricular ejection fraction ≤35%) and New York Heart Association (NYHA) class II/III: Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) or group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment. Analysis of biochemical parameters, cardiopulmonary exercise testing, and echocardiographic evaluation was performed at baseline and 6 months later. The primary outcome was the change in LVEF%, Lipo A, troponin I, NT-Pro BNP and neopterin levels. The secondary outcome is reporting efficacy and safety of sacubitril/valsartan vs Valsartan use and the relationship between NYHA and EF and biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blind randomized controlled trial
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HF were enrolled if aged > 35 years,
- •Stable symptomatic systolic chronic HF (≥ 4 weeks), with left ventricular ejection fraction (LVEF) < 35%,
- •NYHA class II-III,
- •Sinus rhythm and resting HR ≥ 70 beats/min on optimised standard medical therapy.
排除标准
- •Patients with acute decompensation,
- •Cerebrovascular events during the previous 6 months,
- •Pregnancy, breastfeeding,
- •Any valve dysfunction/abnormality,
- •Active myocarditis,
- •Second-degree and third-degree atrioventricular block,
- •Sick sinus syndrome.
研究组 & 干预措施
Group 1 (N = 40)
Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment.
干预措施: Sacubitril / Valsartan Oral Tablet (Drug)
Group 2 (N = 40)
group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.
干预措施: Valsartan 80 mg (Drug)
结局指标
主要结局
LVEF %
时间窗: 6 months
left ventricular ejection fraction percent
Lipo A (pg/ml)
时间窗: 6 months
Lipo protien A (pg/ml)
Troponin.I (ng/ml)
时间窗: 6 months
Troponin.I (ng/ml) biomarker
NT-Pro BNP
时间窗: 6 months
NT-pro BNP(pg/ml) biomarker
Neopterin (nmol/l)
时间窗: 6 Months
Neopterin biomarker
次要结局
未报告次要终点
研究者
Rehab Werida
Associate Professor
Damanhour University